Microchimeric Cell Tranfer From Mother to Child - Pilo Study

Breastfeeding Clinical Trial

Official title:

Identifying and Quantifying Microchimeric Maternal Cells in Young Males, Potentially Acquired Through Breastfeeding - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250219
• Other study ID #: RECHMPL21_0724
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Montpellier
• Contact: Franck PELLESTOR, MD PHD
• Phone: 06.29.04.83.18
• Email: f-pellestor[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Microchimeric cells are known to be transferred from mother to child through the placenta. However it has been postulated that they could also be transferred through breastfeeding.

This study is designed to analyse lymphoid and digestive tract tissues (tonsils and appendixes) in male infants (or young adults) to research microchimeric female cells and try to correlate the frequency and localisation of said cells to the breastfeeding status during early infancy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 16 Years

Eligibility

Inclusion criteria:

• age 1-16 years (at the time of surgery)

• male

• known breastfeeding status in infancy

Exclusion criteria:

• premature birth (before 37 weeks)

• history of blood transfusion

• history of bone marrow transplant

• history of organ transplant

• patient known to have a twin

• known gonosomal

Related Conditions & MeSH terms

• Breastfeeding

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify microchimeric cells of maternal origin in lymphoid	To identify microchimeric cells of maternal origin in lymphoid in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells.	day 1
Primary	To identify microchimeric cells of maternal origin in digestive tissues	To identify microchimeric cells of maternal origin in digestive tissues in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells.	day 1
Primary	to determine Quantifying the microchimeric cells	Quantifying the microchimeric cells : Cell quantification will be assessed through FISH staining (automated cell counting) and qPCR	day 1
Primary	to determine locating the cells in tissues	locating the cells in tissues : Appendix histology slides will be analysed after FISH staining to locate the microchimeric cells	day 1
Primary	to determine trying to find a correlation between breastfeeding status	trying to find a correlation between breastfeeding status : Microchimeric cell quantification will be confronted to the breastfeeding status in infancy (collected during patient inclusion) to validate a correlation	day 1